Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
Clinical trial RSV PED-003 entitled: “A phase II, randomized, observer-blinded, controlled, multicenter trial to evaluate safety, reactogenicity, efficacy, and immunogenicity of GSK Biologicals’ respiratory syncytial virus (RSV) investigational vaccine based on the RSV viral proteins F, N, and M2-1 encoded by chimpanzee-derived adenovector (ChAd155-RSV) (GSK3389245A) when administered intramuscularly according to a 2-dose schedule to infants aged 3 to 7 months at first intervention administration.”

Proposed period of release:
01/06/2021 to 30/06/2023

Name of the Institute(s) or Company(ies)
GlaxoSmithKline Biologicals, Rue de l’Institut, 89
1330 Rixensart, Belgium;

3. Is the same GMO release planned elsewhere in the Community?
Spain; Finland; Italy; Estonia; Poland; Bulgaria;

Has the same GMO been notified elsewhere by the same notifier?

If yes, notification number(s):

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Order of the parental organism: Adenoviridae
Genus of the parental organism: Mastadenovirus
Species of the parental organism: Simian Adenovirus Subgroup C

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Chimpanzee adenovirus type 155MastadenovirusSimian adenovirusN/Aserotype 155N/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known